A Mass Balance Study of [14C]HRS-1780 in Healthy Adult Male Subjects
ConditionChronic Kidney Diseases
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorShandong Suncadia Medicine Co., Ltd.
About this trial
The study aims to evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of \[14C\]HRS-1780 following an oral single dose in healthy adult male participants.
Eligibility criteria
Qualifiers
Before the trial, sign the informed consent form, fully understand the trial content, process and possible adverse reactions, and be willing to complete the research as required by the trial protocol.
Aged 18 to 45 years old (inclusive) who are in good health and have signed the informed consent form on that day.
Body weight of no less than 50 kg and a body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 (inclusive).
Participants (including their partners) shall have no intention to have children or donate sperm within three months after signing the informed consent form and shall voluntarily adopt the contraceptive measures stipulated in the protocol.
Disqualifiers
Clinically significant abnormalities in vital signs (complete physical examination, laboratory tests, biochemistry, urinalysis, coagulation function, stool routine and occult blood, thyroid function), 12-lead electrocardiogram, digital rectal examination, chest X-rays, abdominal ultrasound.
Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HbcAb), hepatitis C virus (HCV Ab), human immunodeficiency virus (HIV), or syphilis at screening.
Receipt of medical devices or another investigational drug (including placebo) within the previous 3 months or within the 5 half-lives (whichever is longer), and plan to participate in other clinical trials of drugs or medical devices during the trial period.
History of illicit or prescription drug abuse in the past five years or drug addiction within 3 months of screening, or positive urine drug screen at screening/baseline.
Trial design
Treatments tested in this trial
- [14C]HRS-1780
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov